These trials completed more than 12 months ago and should have reported results.

These trials are not yet due to report results: some are ongoing, some completed within the past 12 months.

These trials have problematic data on the registry. Details why »

Status Trial ID Title Completion date Category
Reported results 2007-001424-12 A Study of INT-747 (6-ECDCA) Monotherapy in Patients with Primary Biliary Cirrhosis 2017-09-25 due-trials
Reported results 2007-001425-10 A Study of INT-747 (6-ECDCA) in Combination with Ursodeoxycholic Acid (URSO®, UDCA) in Patients with Primary Biliary Cirrhosis 2011-01-19 due-trials
Reported results 2010-023241-29 A Pilot Study to Evaluate the Safety, Tolerability and Efficacy of Obeticholic Acid (INT-747) for the Treatment of Portal Hypertension (PESTO) 2014-02-20 due-trials
Reported results 2011-004728-36 A Phase 3, Double Blind, Placebo Controlled Trial and Long Term Safety Extension of Obeticholic Acid in Patients with Primary Biliary Cirrhosis 2018-12-27 due-trials
Reported results 2014-002205-38 A Phase 2, Randomized, Double-Blind, Placebo-Controlled,Dose-Finding, Clinical Trial Evaluating the Efficacy and Safety of Obeticholic Acid in Subjects with Primary Sclerosing Cholangitis Uno studi... 2018-03-22 due-trials
Listed as ongoing, but also has a completion date and reported results 2014-004693-42 A Multicenter, Open Label, Single- and Multiple-Dose, Dose Finding Study to Assess the Effects of Obeticholic Acid in Pediatric Subjects with Biliary Atresia 2023-03-09 bad-data
Listed as ongoing, but also has a completion date and reported results 2014-005012-42 A Phase 3b, Double Blind, Randomized, Placebo Controlled, Multicenter Study Evaluating the Effect of Obeticholic Acid on Clinical Outcomes in Subjects with Primary Biliary Cirrhosis 2021-12-23 bad-data
Listed as ongoing, but also has a completion date and reported results 2015-002560-16 A Phase 3, Double-Blind, Randomized, Long-Term, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of Obeticholic Acid in Subjects with Nonalcoholic Steatohepatitis 2023-09-15 bad-data
Listed as ongoing, but also has a completion date and reported results 2017-000474-11 A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Obeticholic Acid in Subjects with Compensated Cirrhosis due to Nonalcoholic Steatohepa... 2022-09-08 bad-data
Reported results 2017-001762-13 A Phase 4, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Pharmacokinetics and Safety of Obeticholic Acid in Patients with Primary Biliary Cholangitis and Moderate to Severe Hepatic... 2021-07-09 due-trials
Ongoing 2018-002575-17 A Phase 2, Double-Blind, Randomized, Parallel Group Study Evaluating the Efficacy, Safety, and Tolerability of Obeticholic Acid Administered in Combination with Bezafibrate in Subjects with Primary Bi... not-yet-due
Other 2022-001241-20 A Phase 2a, Double-Blind, Randomized, Active Controlled, Parallel Group Study Evaluating the Efficacy, Safety, and Tolerability of Bezafibrate Administered in Combination with Obeticholic Acid in Subj... not-yet-due
Other 2022-001639-10 A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-escalation, Proof-of-Concept Study Evaluating the Safety, Tolerability, Efficacy and Pharmacokinetics of INT-787 in Subjects... not-yet-due